Steven R. Cohen

Cleft Palate Fistulas: A Multivariate Statistical Analysis of Prevalence, Etiology, and Surgical Management

A retrospective, multivariate statistical analysis of 129 consecutive nonsyndromic patients undergoing cleft palate repair was performed to document the incidence of postoperative fistulas, to determine their cause, and to review methods of surgical management. Nasal-alveolar fistulas and/or anterior palatal fistulas that were intentionally not repaired were excluded from study. Cleft palate fistulas (CPFs) occurred in 30 of 129 patients (23 percent), although nearly a half were 1 to 2 mm in size. Extent of clefting, as estimated by the Veau classification, was significantly more severe in those patients who developed cleft palate fistula. Type of palate closure also influenced the frequency of cleft palate fistula. Forty-three percent of patients undergoing Wardill-type closures developed cleft palate fistula versus 10, 22, and 0 percent for Furlow, von Langenbeck, and Dorrance style closures, respectively. The fistula rate was similar in patients with (30 percent) and without (25 percent) intravelar veloplasty. Age at palate closure did not significantly affect the rate of fistulization; however, the surgeon performing the initial closure did have an effect. Thirty-seven percent of patients developed recurrent cleft palate fistulas following initial fistula repair. Recurrence of cleft palate fistulas was not influenced by severity of cleft or type of original palate repair. Following end-stage management, a second cleft palate fistula recurrence occurred in 25 percent of patients. Continued open discussion of results of cleft palate repair is recommended.

Mandibular distraction osteogenesis in the treatment of upper airway obstruction in children with craniofacial deformities.

&NA; Over the past 3 years, 16 patients (12 males, 4 females) have undergone mandibular distraction osteogenesis in conjunction with soft‐tissue procedures to treat medically refractory obstructive sleep apnea. Thirty distraction devices were placed for bilateral distraction in 14 children and unilateral distraction in 2. The mean age of treatment was 4 years and 8 months (range 14 weeks to 12 years and 8 months). Eight of the patients had failed conventional medical and surgical treatment of obstructive sleep apnea and were considered tracheostomy candidates, whereas the remaining eight had tracheostomies placed shortly after birth for upper airway obstruction. These eight children could not be decannulated by standard protocols. The average distraction distance was 25 mm (range 18 to 35 mm). To date, seven of the eight patients with tracheostomies have been decannulated, and one is still in progress. Clinical improvement in the signs and symptoms of sleep apnea and reduction or elimination of preoperative oxygen requirements occurred in seven of the eight children with medically refractory sleep apnea. Twelvechannel polysomnograms were obtained preoperatively and postoperatively in each of the eight patients without tracheostomies. Respiratory disturbance index decreased from a mean of 7.1 to 1.7 after surgery. Lowest oxygen saturation rose from a mean of 0.70 to 0.89 after surgery. Application of mandibular distraction osteogenesis is an important component in the treatment of obstructive sleep apnea and permits mandibular advancement in the younger child. As more experience is gained with distraction osteogenesis in the treatment of children with obstructive sleep apnea, the role of distraction will become better defined. (Plast. Reconstr. Surg. 101: 312, 1998.)

An overview of permanent and semipermanent fillers

Summary: The demand for safe, effective, long-lasting, biocompatible dermal filler materials is increasing. Many products that include synthetic polymers and autologous tissue have emerged that attempt to meet these criteria. An overview of injectable permanent fillers, including ArteFill, Aquamid, and silicone, and semipermanent fillers, including Radiesse, Sculptra, and autologous fat, is presented. A discussion of their composition, histologic characteristics, antigenicity, U.S. Food and Drug Administration approval status, indications for use, efficacy, injection technique, and adverse effects is provided.

Maxillary-midface distraction in children with cleft lip and palate: a preliminary report.

A miniature system of distraction devices has been employed for maxillary-midface advancement in two children with cleft lip and palate, class III malocclusion, and associated midfacial hypoplasia. The devices are made with commercially available palatal expansion screws linked to rigid fixation plates. A midfacial osteotomy is used, and distraction is begun on the third postoperative day. In the first child, a 7-year-old boy, the midface was distracted 11 mm sagittally and 4 mm inferiorly. In the second patient, a 4 1/2-year-old girl with unilateral cleft lip and palate and midfacial retrusion, an 11-mm distraction was carried out in the vertical and sagittal direction. There were no complications, and none of the devices failed. Maxillary-midfacial distraction osteogenesis to correct severe maxillary-midfacial hypoplasia in children with clefts and other craniofacial disorders permits early intervention with potentially less invasive techniques than are currently available.

Craniofacial distraction with a modular internal distraction system: evolution of design and surgical techniques.

The present report summarizes the evolution of design for a modular internal distraction system that is applicable throughout the craniofacial region. Eleven patients (5 boys, 6 girls), whose ages ranged from 4 months to 10 years at the time of distraction, constitute the basis for this study. The clinical indications for distraction were exorbitism with corneal exposure (n = 1), obstructive sleep apnea (n = 4), tracheostomy decannulation (n = 1), severe maxillary hypoplasia with class III malocclusion (n = 3), severe vertical and sagittal maxillary deficiency with anophthalmia (n = 1), and relapse following frontoorbital advancement in a case of rare craniofacial clefting (n = 1). Twenty-two distraction devices were used in these 11 patients. Two initial prototypes were tested (prototype 1 = 8 devices; prototype 2 = 2 devices) until the modular internal distraction system (MIDS, Howmedica-Leibinger, Inc.) was developed (n = 12 devices). The craniofacial osteotomies used were Le Fort III (n = 4), monobloc (n = 3), mandibular (n = 3), Le Fort I (n = 2), and cranial (n = 1). The distraction distances ranged from 11 to 28 mm. One patient undergoing mandibular distraction developed transient swelling in the left mandibular region, which responded to antibiotics. There were no other complications. Depending on the age of the patient and the length of distraction, the distraction gap was allowed to consolidate from 6 weeks to 3 months. The devices were then removed on either an outpatient or a 23-hour-stay basis. The modular internal distraction system permits widespread application of easily customizable, buried distraction devices throughout the craniofacial region.

Artecoll: A Long-lasting Injectable Wrinkle Filler Material: Report of a Controlled, Randomized, Multicenter Clinical Trial of 251 Subjects

Artecoll, an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, is widely available outside the United States. For domestic availability, a multicenter Investigational Device Exemption study was required by the U.S. Food and Drug Administration. This study consisted of 251 subjects at eight centers who received injections of Artecoll or the currently approved collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial fold, radial upper lip lines, and corner-of-the-mouth lines. The treatments were randomized, and follow-up safety, efficacy, investigator success rating, and subject satisfaction rating data were collected at 1, 3, and 6 months. The safety data, measured as adverse events and immunoglobulin G serum levels, were low and similar for both groups. The efficacy data, measured by masked observers using a photographic facial fold assessment scale, demonstrated a combined significant improvement with Artecoll compared with collagen at 6 months (p < 0.001). At 6 months, the investigator success ratings and the subject satisfaction ratings for each of the four injections sites were superior for Artecoll (p < 0.001). In the Artecoll group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant augmentation. Artecoll had fewer adverse events reported throughout the 12-month safety study period than the control group did in 6 months, although the difference was not statistically significant.

Mammographic changes following reduction mammaplasty.

Mammographic findings after reduction mamma-plasty may be similar to those seen with carcinoma. A knowledge of ihe expected mammographic alterations would be helpful in differentiating postoperative changes from those seen with carcinoma of the breast. Accordingly, the clinical records and mammograms of patients who underwent reduction mammaplasty at the Dartmouth-Hitchcock Medical Center between March of 1977 and July of 1985 were analyzed. Forty-two patients had at least one mammographic examination following reduction mammaplasty. Peri-areolar soft-tissue changes and inferior pole alterations were present in almost all examinations of patients during the first 6 months after operation, but they decreased during the next few years. Asymmetrical densities were present in approximately half the patients throughout the follow-up period but decreased in degree. Parenchymal calcifications occurred later; few x-rays showed these calcifications during the first year, but 50 percent were apparent after 2 years. Evidence of fat necrosis occurred in approximately 10 percent. Four patients had biopsies for suspicious densities. Chronic inflammation and inclusion cyst were reported. We believe that changes after reduction mammaplasty are predictable and can usually be differentiated from those associated with cancer.

Iliac crest bone graft harvesting techniques: a comparison.

This study was undertaken to compare the morbidity of traditional iliac bone graft harvesting techniques for grafting alveolar clefts to minimally invasive techniques. Fiftyfive age‐matched patients, ages 6.5 to 16 years (mean, 11.2 years), 22 girls and 33 boys, were divided into three groups. The traditional bone window open harvesting technique served as the control group. Two different minimally invasive techniques, one that used a bone grinder and another that used a trephine, for bone harvesting were compared with the control. Both invasive techniques were statistically superior, p < 0.05, in terms of total time pain medication was necessary (mean of 12.0 hours for bone grinder, 17.6 hours for trephine, 26.0 hours for control), operative time for bone harvest (mean of 11 minutes for bone grinder and trephine, 20 minute for control), and mean incision length (2 cm for bone grinder and trephine, 5 cm for control). Patients exposed to the minimally invasive techniques had fewer complications, a trend toward earlier ambulation, and shorter hospital stays when compared with the bone grinder technique. The patients exposed to the bone grinder demonstrated earlier ambulation and fewer requirements for analgesia when compared with the trephine technique, although these results did not reach statistical significance. The trephine technique was useful when maxillary osteotomies were combined with alveolar bone grafting, because it provided structural bone grafts and cancellous bone. On the basis of these findings, the bone grinder is the preferred technique for harvesting alveolar bone grafts when no structural support is required. These authors no longer use the traditional bone window open harvesting technique. (Plast. Reconstr. Surg. 105: 34, 2000.)

ArteFill : A long-lasting injectable wrinkle filler material-summary of the U.S. Food and Drug Administration trials and a progress report on 4- to 5-year outcomes

Summary: ArteFill, the successor product to Artecoll, is an injectable wrinkle filler composed of polymethylmethacrylate microspheres and bovine collagen, which offers long-lasting and probably permanent augmentation of wrinkles and skin contour deformities. The pivotal U.S. Food and Drug Administration study consisted of 251 subjects at eight centers in the United States who received injections of ArteFill or bovine collagen dermal filler (control) in 1334 wrinkles of the glabella, nasolabial folds, radial upper lip lines, and corners of the mouth. The efficacy data generated by masked observers using a photographic Facial Fold Assessment Scale demonstrated a significant improvement with ArteFill compared with collagen at 6 months (p < 0.001) in the nasolabial folds. In the ArteFill group, 12-month follow-up was obtained for 111 subjects (86.7 percent) and showed persistence of significant wrinkle correction. A subgroup of 69 patients who received ArteFill were recalled 4 to 5 years later. Five patients reported six late adverse events that occurred from 2 to 5 years after the initial injection; four of the adverse events were mild cases of lumpiness and two were severe. The total number of late adverse events was six of 272 (2.2 percent) wrinkles injected. Among the 272 wrinkles evaluated at 5 years, two events (0.7 percent) in one patient were rated as severe (a nodular, minimally inflammatory to noninflammatory reaction in both nasolabial folds). Investigator Facial Fold Assessment ratings at 4 to 5 years were improved from baseline by 1.67 points (p < 0.001).

The use of hydroxyapatite cement in secondary craniofacial reconstruction.

Sixty-one patients underwent secondary craniofacial reconstruction for contour defects using hydroxyapatite cement over a 3-year period (20-month mean follow-up). There were 56 children, aged 2.2 to 18 years (mean, 10.7 years), 21 boys and 35 girls. This is the first series of pediatric patients in whom the use of hydroxyapatite cement has been reported. There were five adults aged 21 to 46 years (mean, 32 years), 3 men and 2 women. Thirty-one patients underwent reconstruction for secondary orbitocranial defects after surgery for synostosis, 7 after surgery for hypertelorism, 10 for posttraumatic skull defects, and 13 for a variety of other facial skeletal defects. There were seven complications (11 percent), ranging from a retained drain to postoperative seromas, all of which required reoperation without loss of the contour correction. All of the complications occurred in the first 18 months of our study. There has been excellent retention of implant volume with no recurrence of contour defects to date. We have not found any visible evidence of interference with craniofacial growth over the study period. We conclude that hydroxyapatite cement is a versatile and safe biomaterial when used for the correction of secondary craniofacial contour defects in children and adults. The coupling of antibiotics with this biomaterial may have applications in the treatment of osteomyelitis.